Disability PhysicalNCT04723381
The Effect of Web Based Genital Hygiene Education Provided to Orthopedically Disabled Women
A study testing web based education in people with Disability Physical and Genital Infection, run by Siirt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disability Physical, Genital Infection
- What is being tested?
- web based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being orthopedically handicapped
- Being literate, being over the age of 18
- Having access to the internet
- Being able to use the internet/computer
- Being able to maintain genital hygiene individually.
Who cannot join
- The inability to use the internet
- Not being a member of the website
- Having mental retardation
- Being dependent on someone else to maintain genital hygiene (bedridden, with spasticity)
- No willing to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 15-Week Randomized Controlled Trial in Orthopedically Disabled Women
The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors.
Read the detailed description
It was a randomized controlled trial. The women in the experimental group were given web-based genital hygiene education that continued for seven weeks. No intervention was applied to the women in the control group.
- Conditions
- Disability Physical, Genital Infection
- Being tested
- web based education
- Keywords
- web based education, disabled women, genital hygiene, self care agency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based educationOther
Expert support and consultancy were received for the design and preparation of the web page.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Partivipants recieved web based genital hygiene education for seven week Receives: Other: web based education |
| Control | No intervention | No intervention was applied to the women in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Questionnaire
The introductory questionnaire created for descriptive expressions
Measured: Baseline
Change from the Baseline Self-Care Agency Scale Points at 7th and 15th weeks
Self-Care Agency Scale was used to determine the self-care skills and abilities of the participants. It is a 5-point Likert-type scale with 35 items. Each item of the scale is scored between 0 and 4 (0= very uncharacteristic of me, 4= very characteristic of me). In the scale, 8 items (3, 6, 9, 13, 19, 22, 26, and 31) are scored reversely (0= very characteristic of me, 4= very uncharacteristic of me). The scale is evaluated over 140 points. In evaluation, the score over 120 points is defined as high, the score between 82 and 120 points is defined as moderate, and the score below 82 points is defined as low.
Measured: Baseline, at the end of the 7th week, at the end of the 15th week
Change from the Genital Hygiene Behavior Scale Points at 7th and 15th weeks
The Genital Hygiene Behavior Scale was used to determine the genital hygiene behaviors of the participants.It is a 5-point Likert-type scale with 23 items consisting of three sub-dimensions. The sub-dimensions of the scale are "General Hygiene (the first 12 items)", "Menstrual Hygiene (items between 13 and 20), and "Abnormal Finding Awareness (items between 21 and 23 )". Participants rate each item from 1 to 5 according to their suitability (1 = strongly disagree, 5 = Strongly agree). In the scale, 5 items (7, 14, 19, 20, 23) are scored reversely (1 = strongly agree, 5 = Strongly disagree). The highest score that can be obtained from the scale is 115 and the lowest score is 23. High scores indicate positive genital hygiene behavior.
Measured: Baseline, at the end of the 7th week, at the end of the 15th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Sidar Gül, Siirt University
- Investigators
- Yurdagul Yagmur, Prof, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723381
- Sponsor's protocol ID
- 1648
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 15-Week Randomized Controlled Trial in Orthopedically Disabled Women
- ClinicalTrials.gov ID
- NCT04723381
- Acronym / sponsor ID
- 1648
- Conditions
- Disability Physical, Genital Infection
- Keywords
- web based education, disabled women, genital hygiene, self care agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors.
Detailed description
It was a randomized controlled trial. The women in the experimental group were given web-based genital hygiene education that continued for seven weeks. No intervention was applied to the women in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: web based educationPartivipants recieved web based genital hygiene education for seven week |
| Control | No intervention | –No intervention was applied to the women in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being orthopedically handicapped
- Being literate, being over the age of 18
- Having access to the internet
- Being able to use the internet/computer
- Being able to maintain genital hygiene individually.
Key exclusion criteria (5 listed)
- The inability to use the internet
- Not being a member of the website
- Having mental retardation
- Being dependent on someone else to maintain genital hygiene (bedridden, with spasticity)
- No willing to complete the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web based educationExpert support and consultancy were received for the design and preparation of the web page. | Other | Experimental |
Primary outcome
Introductory Questionnaire
Time frame: Baseline
The introductory questionnaire created for descriptive expressions
Change from the Baseline Self-Care Agency Scale Points at 7th and 15th weeks
Time frame: Baseline, at the end of the 7th week, at the end of the 15th week
Self-Care Agency Scale was used to determine the self-care skills and abilities of the participants. It is a 5-point Likert-type scale with 35 items. Each item of the scale is scored between 0 and 4 (0= very uncharacteristic of me, 4= very characteristic of me). In the scale, 8 items (3, 6, 9, 13, 19, 22, 26, and 31) are scored reversely (0= very characteristic of me, 4= very uncharacteristic of me). The scale is evaluated over 140 points. In evaluation, the score over 120 points is defined as high, the score between 82 and 120 points is defined as moderate, and the score below 82 points is defined as low.
Change from the Genital Hygiene Behavior Scale Points at 7th and 15th weeks
Time frame: Baseline, at the end of the 7th week, at the end of the 15th week
The Genital Hygiene Behavior Scale was used to determine the genital hygiene behaviors of the participants.It is a 5-point Likert-type scale with 23 items consisting of three sub-dimensions. The sub-dimensions of the scale are "General Hygiene (the first 12 items)", "Menstrual Hygiene (items between 13 and 20), and "Abnormal Finding Awareness (items between 21 and 23 )". Participants rate each item from 1 to 5 according to their suitability (1 = strongly disagree, 5 = Strongly agree). In the scale, 5 items (7, 14, 19, 20, 23) are scored reversely (1 = strongly agree, 5 = Strongly disagree). The highest score that can be obtained from the scale is 115 and the lowest score is 23. High scores indicate positive genital hygiene behavior.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yurdagul Yagmur, Prof study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web based education in people with Disability Physical and Genital Infection, run by Siirt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Questionnaire (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.